1. Field of the Invention
The present invention relates to a device for penetrating tissue and delivering bioactive agents thereto or extracting biological materials therefrom.
More particularly, the present invention relates to tissue penetration devices for delivering biologically active agents into tissue sites or extracting biological materials from the tissue sites where the device includes specially designed needles for penetrating a tissue site either rotationally or non-rotationally and specially designed delivery or extraction devices for controlled delivery of materials into tissue sites or extraction of materials from tissue sites.
2. Description of the Related Art
Accurate and effective tissue penetration and accurate and effective delivery of bioactive agents or extraction of biological fluids or material is regime of needle incorporating devices. Several patents have dealt with such needle incorporating devices including the following U.S. Pat. Nos. 1,523,068, 2,773,500, 2,773,501, 3,788,320, 3,811,442, 3,893,445, 4,666,438, 4,787,893, 4,969,870, 5,176,643, 5,271,744, and 5,312,364.
Although these patents generally relate to syringe and needle assemblies for the delivery of material into or extraction of material out of a tissue site, there is still a need in the art for new, efficient and controlled delivery and extraction devices incorporating new, efficient needles which reduce penetration time and improve penetration efficiency into sensitive tissue sites.
The present invention provides a device for delivering materials into or extracting materials from tissue sites. The device includes a fluid reservoir, a tissue penetrator or needle detachably engaging a first end of the reservoir and a plunger associated with the reservoir at its second end and designed to slidingly engage an interior surface of the reservoir. The device further includes at least one solenoid having a shaft detachably engaging a top of the plunger for moving the plunger within the reservoir, a power supply and associated circuitry for supply electrical power to the solenoid and at least one switch for controlling the solenoid. Preferably, the entire assembly is contained within a housing including a biased retractable tip protector (preferably, disposable) at its distal end having a penetrator. Additional solenoids can be used to control needle penetration speed and depth or to allow simultaneous or sequential infusion or removal of materials into or out of a tissue site.
The present invention provides a device for delivering materials into or extracting materials out of tissue sites. The device includes a reservoir/solenoid assembly as described above and additionally, a motor assembly for rotating the solenoid/reservoir assembly and at least one control switch with associated circuitry for activating the motor either in cooperation with the solenoid or independent from the switches and circuitry associated with the solenoid. Again, additional solenoids can be used to control needle penetration speed and depth by pushing against the motor assembly coordinated with needle rotation or to allow simultaneous or sequential infusion or removal of materials into or out of a tissue site.
The present invention also provides a tissue penetrator or needle including a hollow tubular member having a first end, a second end having a tissue penetrating tip associated therewith and at least one perforation therein located between a mid point of the hollow member and the tip end of the hollow member. The tissue penetrating tip includes two opposed cutting surfaces, each having a cutting edge, two opposed non-cutting surfaces and an opening associated with the tip at or near the apex. The hollow member can also include an enlarged region or seal for creating a seal between the penetrated tissue site and the penetrator.
This invention also provides a method for delivering material to a tissue site including positioning a tissue penetration device as described above in proximity to a tissue site to be penetrated, penetrating the tissue site with the penetrator, and activating the solenoid to deliver material into the tissue site from the reservoir of the penetration device or transfer material from the reservoir to the tissue site.
The present invention also provides a method for extracting material from a tissue site including positioning a tissue penetration device as described above in proximity to a tissue site to be penetrated, penetrating the tissue site with the penetrator, and activating the solenoid to extract material from the tissue site or transfer material from the tissue site to the reservoir.
This invention also provides a method for delivering material to a tissue site including positioning a tissue penetration device as described above in proximity to a tissue site to be penetrated, rotationally penetrating the tissue site with the penetrator, and activating the solenoid to transfer material from the reservoir to the tissue site.
The present invention also provides a method for extracting material from a tissue site including positioning a tissue penetration device as described above in proximity to a tissue site to be penetrated, rotationally penetrating the tissue site with the penetrator, and activating the solenoid to transfer material from the tissue site to the reservoir.